Outline

Background and aims: Opioids are the most potent analgesics and are well established in the treatment of severe pain. Sufficient data from literature sources is not available for a complete and precise presentation of all emerging costs of back pain therapy with strong opioids (WHO-step III opioids). Neither long-term studies, nor randomized clinical trials or health services research studies have been conducted with regard to effectiveness of these therapies. Health services research evaluates how patients suffering from chronic back pain are treated in terms of outcome, i.e. ambulant treatment, days of hospitalization and related costs. This observational study aimed at assessing health-related quality of life, total costs of patients and effectiveness of the therapy with oxycodone/naloxone or other strong opioids under daily routine conditions in Germany.

Materials and methods: A non-interventional study (NIS) design was chosen to evaluate actual costs incurred for patients suffering from chronic back pain in Germany. Two cohorts were observed: Patients in the first cohort were treated with oxycodone/naloxone and in the second cohort with other strong opioids. Opioid-naive and opioid-pretreated female and male adults (>18 years) suffering from chronic back pain below the costal arch and above the gluteal groove, who require a round-a-clock-treatment with strong opioids, were eligible for participation. Patients with cancer pain, herniated vertebral disks, or pain caused by an accident, were excluded. 131 general practitioners and orthopaedics participated in this NIS and altogether enrolled 1013 patients who were observed for one year. Of these, 970 patients could be evaluated and about 4.25% were drop-outs. Treatments were documented on standardized documentation forms. Patients were enquired about intensity, character and duration of their chronic back pain as well as its consequence on daily activities, social contacts and working life, by means of for example BPI-SF and SF-36 questionnaires, interviews and numeric event scales. For evaluation of the costs, all relevant costs related to chronic back pain were calculated.

Results: Within the last 12 months before visit 1, almost 15.8% of the patients were unable to work due to chronic pain for about 83.3 days on average (cohort 1: 75.6; cohort 2: 99.6). 77.6% of the back pain was caused by a musculosceletal system disease, especially degenerative spine disease. The results indicate significant superiority especially in the effectiveness and quality of life with treatment of oxycodone/naloxone compared to other strong opioids. After one year, direct costs for cohort 1 patients amounted to 2403.45 € compared to 2772.98 € for cohort 2 patients. Hence therapy costs for patients treated with oxycodone/naloxone were 369.53 € lower than therapy costs for patients treated with other strong opioids. Direct costs include ambulant treatment, type and amount of prescribed and advised drugs, non-drug therapies, hospitalization, emergency treatment, rehabilitation as well as additional acquirements caused by this disease.

Conclusions: Patients treated with oxycodone/naloxone experienced better quality of life, superior effectiveness and less back pain after 12 months compared to patients treated with other strong opioids. The analysis of costs showed that treatment with oxycodone/naloxone generated lower direct costs compared to other strong opioids.